FDA 510(k) Applications for Medical Device Product Code "LIQ"
(Enzyme Linked Immunoabsorbent Assay, Rotavirus)

FDA 510(k) Number Applicant Device Name Decision Date
K874375 ABBOTT LABORATORIES ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL 12/10/1987
K880821 ABBOTT LABORATORIES RESUBMITTED ABBOTT TESTPACK ROTAVIRUS 05/06/1988
K853399 ARMKEL, LLC. VIROGEN ROTATEST SLIDE TEST 11/12/1985
K861172 BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. ROTAVIRUS LATEX AGGLUTINATION ASSAY 07/01/1986
K841243 BEHRING DIAGNOSTICS, INC. ENZYGNOST ROTAVIRUS AG 10/17/1984
K915137 BIO-RAD LABORATORIES, INC. KALLESTAD ROTAVIRUS MICROPLATE 03/04/1992
K972895 BIOMERIEUX VITEK, INC. VIDAS ROTAVIRUS (RTV) ASSAY 10/03/1997
K965092 BIOMERIEUX VITEK, INC. VIDAS ROTAVIRUS ASSAY 05/05/1997
K852969 CAMBRIDGE BIOSCIENCE CORP. ROTACLONE ROTAVIRUS DIAGNOSTIC KIT 11/05/1985
K912666 DAKO CORP. DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 02/14/1992
K932384 DAKO DIAGNOSTICS LTD. IDEIA(TM) ROTAVIRUS 12/27/1993
K884017 DIFCO LABORATORIES, INC. ROTACUBE 01/24/1989
K951208 ELDAN TECHNOLOGIES, LTD. ROTA-DAN RAPID ROTAVIRUS EIA KIT 02/14/1996
K864811 INTL. DIAGNOSTIC LABORATORIES, LTD. ROTA-STAT 08/25/1987
K843367 INTL. DIAGNOSTIC LABORATORIES, LTD. ROTAVIRUS ENZYME IMMUNOASSAY 06/13/1985
K853554 KALLESTAD LABORATORIES, INC. PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS 11/26/1985
K862917 KALLESTAD LABORATORIES, INC. PATHFINDER ROTAVIRUS CHEMILUMINESCENT 10/22/1986
K834443 LITTON BIONETICS ROTAVIRUS BIO-ENZABEAD SCREEN KIT 03/16/1984
K873740 MERCIA DIAGNOSTICS LTD. ROTASCREEN EIA 11/27/1987
K933587 MERIDIAN DIAGNOSTICS, INC. IMMUNOCARD ROTAVIRUS 02/03/1994
K971585 MERIDIAN DIAGNOSTICS, INC. IMMUNOCARD STAT! ROTAVIRUS 08/20/1997
K850269 MERIDIAN DIAGNOSTICS, INC. MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE 07/18/1985
K860529 ORION CORP. ROTALEX 03/04/1986
K942286 ORION DIAGNOSTICA, INC. DIARLEX ROTA-ADENO 12/14/1994
K854129 ORION DIAGNOSTICA, INC. ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS 01/21/1986
K841319 ORION DIAGNOSTICA, INC. ROTALEX LATEX AGGLUTINATION TEST 09/14/1984
K883935 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO* ROTAVIRUS ANTIGEN ELISA TEST 01/04/1989
K883940 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST 01/04/1989
K990842 SA SCIENTIFIC, INC. SAS ROTA TEST 08/09/1999
K964424 TRINITY BIOTECH, INC. ROTAVIRUS EIA 08/08/1997
K895805 VITEK SYSTEMS, INC. SLIDEX ROTA-KIT 2 02/26/1991
K861634 WELLCOME DIAGNOSTICS THE WELLCOME ROTAVIRUS LATEX TEST ZL40 10/29/1986
K861628 WELLCOME DIAGNOSTICS WELLCOZYME ROTAVIRUS WZ01 01/21/1987


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